(413 days)
Not Found
No
The document describes a standard mechanical ventilator and pulse oximeter with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is a ventilator used for providing continuous positive-pressure ventilation to patients with respiratory failure, which directly treats a medical condition.
No
Explanation: The device is a ventilator, which provides respiratory support, and includes a pulse oximeter for continuous monitoring of SpO2 and pulse rate. While the pulse oximeter monitors physiological parameters, the primary function of the device is therapeutic (ventilation), not diagnostic. Monitoring alone does not make a device diagnostic; diagnosis involves the identification of a disease or condition.
No
The device description explicitly states it is a "portable mechanical ventilator" and mentions hardware components like an integrated battery system and external power sources. It also details testing for electrical safety and EMC, which are hardware-related.
Based on the provided text, the ZOLL 731 Series of Ventilators is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "management of infant through adult patients... by providing continuous positive-pressure ventilation." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "portable mechanical ventilator" that provides "ventilatory support." This aligns with a life-support device, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The pulse oximeter component is also a non-invasive monitoring device, not an IVD.
Therefore, the ZOLL 731 Series of Ventilators is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ventilation
Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.
Pulse Oximetry (SpO2)
The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Product codes (comma separated list FDA assigned to the subject device)
CBK, DQA
Device Description
The ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).
The ventilator can use 6 ft or 12 ft patient circuits to support adult, pediatric, and infant patients. ZOLL provides the following circuit types:
- Pediatric/Adult, 6 ft and 12 ft, intended for use when delivering tidal volume from 200 ml to Adult.
- Infant/Pediatric, 6 ft and 12 ft, intended for use when delivering tidal volume from 50 ml to 300 ml.
The optional Oxygen Reservoir Kit can be used for the following purposes:
- Acts as a reservoir, collecting oxygen during the expiratory phase of ventilation.
- Provides an interface to the ventilator and the attachment of the low-flow oxygen supply hose.
- Provides an inlet in the event the low-flow oxygen supply fails, or the tidal volume is greater than the supplied oxygen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infant through adult patients weighing greater than or equal to 5 kg
adult, pediatric, and neonatal patients
Intended User / Care Setting
skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.
hospitals, hospital-type facilities, or in mobile environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submission for Software Contained Medical Devices, issued June 14, 2023. Extensive testing in the form of the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all its functional requirements and performance specifications."
Safety Testing per International Standards: The device was determined to be compliant with the following internationally recognized test standards as seen in Table 1, including EN 794-3, EN ISO 15223-1, ISO 20417, EN 60601-1, EN 60601-1-2, EN 60601-1-6, IEC 60601-1-8, IEC 60601-1-12, EN 62304, EN 62366-1, EN ISO 10993-1, ISO 10993-5, ISO 10993-10, EN ISO 80601-2-61, EN ISO 13485, EN ISO 14971, ISO 5367, Mil-Std-810G, Mil-Std-461F, RTCA/DO 160, IEC 62133-2, EN 1789, AIM 7351731.
Usability Testing: "No usability validation is included in this plan. The user interface remains unchanged. There is no change in instructions on how to set alarms limits. There are no changes to alarm system audio annunciation, LED response and LCD indication (use of alarm message center, icon area and alarm flashing parameters)."
Electrical Safety and electromagnetic compatibility (EMC): "The 731 Series Ventilator has been tested to meet applicable testing standards listed in Table 1."
Clinical Evidence: "Clinical evidence was not necessary to show substantial equivalence."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
December 13, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Zoll Medical Corporation Jeffrey Churchill Senior Manager, Regulatory Affairs 269 Mill Road Chelmsford, Massachusetts 01824
Re: K233486
Trade/Device Name: 731 Series Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DQA Dated: December 11, 2024 Received: December 11, 2024
Dear Jeffrey Churchill:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director, Respiratory Devices Team DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K233486
Device Name
731 Series Ventilator
Indications for Use (Describe)
Ventilation
Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.
Pulse Oximetry (SpO2)
The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo is in blue and consists of the word "ZOLL" in large, bold letters. Below the word "ZOLL" is the text "an Asahi Kasei company" in a smaller font.
269 Mill Road Chelmsford, MA 01824
978.421.9655 (main) 978.421.0025 (fax) zoll.com
510(K) SUMMARY
Sponsor Information:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824
Contact Person: Jeffrey Churchill Associate Director, Regulatory Affairs Phone: (339) 222-0524 Email: Jeffrey.Churchill(@zoll.com
Date of Summary: December 13, 2024
Device Name and Classification:
510(k) Number: K233486 Trade/Proprietary Name: 731 Series Ventilator Common Name: Transport Ventilator Classification Name: Continuous Ventilator (21 CFR 868.5895) Product Code: CBK, DQA
Predicate Device:
731 Series Ventilators (K162832, cleared 08/02/2017) Regulation Number: 868.5895 Regulatory Class: Class II Product Code: CBK, DQA
Device Description:
The ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume
5
ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).
The ventilator can use 6 ft or 12 ft patient circuits to support adult, pediatric, and infant patients. ZOLL provides the following circuit types:
- . Pediatric/Adult, 6 ft and 12 ft, intended for use when delivering tidal volume from 200 ml to Adult.
- . Infant/Pediatric, 6 ft and 12 ft, intended for use when delivering tidal volume from 50 ml to 300 ml.
The optional Oxygen Reservoir Kit can be used for the following purposes:
- Acts as a reservoir, collecting oxygen during the expiratory phase of ventilation.
- Provides an interface to the ventilator and the attachment of the low-flow oxygen supply hose. ●
- Provides an inlet in the event the low-flow oxygen supply fails, or the tidal volume is greater than the supplied oxygen.
Indications for Use:
Ventilation
Each model of the ZOLL 731 Series of ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.
Pulse Oximetry (SpO2)
The ZOLL ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Comparison of Technological Characteristics:
The 731 Series Ventilator has been in the field for over 10 years. After the recent deployment and use of the ventilators with COVID-19 patients, care providers have identified specific areas for potential
6
improvement. Evolution in the standard of care has changed the level of patient sedation and patient management needs has motivated a comprehensive review of the pneumatic alarm system. This review focused on the patient-ventilator interaction which impacts alarm detection and the ventilator response to the alarm condition. As part of the current submission, ZOLL plans to update the ventilator software to revision 5.25 to improve the alarm logic specifically to target better functionality with COVID-19 patients.
The principles of operation are identical between the predicate ZOLL 731 Series Ventilator (K162832) and the proposed device. The indications for use remain the same from the proposed ZOLL 731 Series Ventilator. The technological difference between the predicate device (K162832) and the proposed device is the introduction of software revision 5.25, which updates the ventilator alarm logic. Changes to the alarm logic were originally released under the FDA Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency as software revision 5.24, followed by intended commercialized software revision 5.25.
Under software revision 5.25, substantial equivalence has been determined to the predicate device, cleared under K162832. The following have been evaluated for substantial equivalence:
- . Alarm System
- . Functions and Features
- Indications for Use ●
- Intended Use ●
- Labeling .
- Pulse Oximeter Specifications ●
- Ventilator Specifications ●
Substantial Equivalence - Non-Clinical Evidence:
The following performance data were provided in support of substantial equivalence determination:
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submission for Software Contained Medical Devices, issued June 14, 2023. Extensive testing in the form of the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all its functional requirements and performance specifications.
Safety Testing per International Standards
The device was determined to be compliant with the following internationally recognized test standards as seen below in Table 1:
7
| FDA Consensus # | Standard Designation | Year |
|---|---|---|
| NR | EN 794-3 | 1998/A2:2009 |
| 5-134 | EN ISO 15223-1 | 2021 |
| 15-135 | ISO 20417 | 2021 |
| 19-4 | EN 60601-1 | 2006/A1:2013 |
| 19-8 | EN 60601-1-2 | 2014 |
| 5-132 | EN 60601-1-6 | 2020 |
| 5-76 | IEC 60601-1-8 | 2012 |
| 19-15 | IEC 60601-1-12 | 2015 |
| 13-79 | EN 62304 | 2006/A1:2016 |
| 5-129 | EN 62366-1 | 2015+A1:2020 |
| 2-258 | EN ISO 10993-1 | 2018 |
| 2-245 | ISO 10993-5 | 2009 |
| 2-174 | ISO 10993-10 | 2010 |
| 1-139 | EN ISO 80601-2-61 | 2017 |
| NR | EN ISO 13485 | 2016 |
| 5-125 | EN ISO 14971 | 2019 |
| 1-103 | ISO 5367 | 2014 |
| NR | Mil-Std-810G | 1/2000 with change C3 |
| (5/2003) | ||
| NR | Mil-Std-461F | 12/2007 |
| NR | RTCA/DO 160 | 2010 |
| 19-33 | IEC 62133-2 | 2017 |
| NR | EN 1789 | 2007+A2:2014 |
| 19-45 | AIM 7351731 | Rev. 3.00 2021-06-04 |
Table 1: 731 Series Ventilator Compliance Standards
Usability Testing
No usability validation is included in this plan. The user interface remains unchanged. There is no change in instructions on how to set alarms limits. There are no changes to alarm system audio annunciation, LED response and LCD indication (use of alarm message center, icon area and alarm flashing parameters).
Electrical Safety and electromagnetic compatibility (EMC)
The 731 Series Ventilator has been tested to meet applicable testing standards listed in Table 1.
Substantial Equivalence -Clinical Evidence:
Clinical evidence was not necessary to show substantial equivalence.
8
Conclusion:
As part of the change control process, the subject device has undergone the appropriate verification and validation testing, all of which confirms that the device meets its design, performance, and safety specifications. The information presented herein provides reasonable assurance of safety and effectiveness while following the least burdensome approach as defined in FDA's Guidance - The Least Burdensome Provisions: Concept and Principles published February 9, 2019. Performance data demonstrates that the features and functions of the subject device are substantially equivalent to those of the predicate device.